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Home Industry News Roche leukaemia drug receives European approval

Roche leukaemia drug receives European approval

29th July 2014

Roche has announced that its leukaemia drug Gazyvaro has been granted approval by the European Commission.

The therapy has been given the green light for use in combination with chlorambucil chemotherapy among patients with previously untreated chronic lymphocytic leukaemia who have comorbidities that make them unsuitable for an intensive therapy.

Data from the CLL1 study showed that Gazyvaro plus chlorambucil was able to significantly reduce the risk of disease worsening or death by 61 percent compared to MabThera/Rituxan plus chlorambucil.

The product becomes the first type II glycoengineered anti-CD20 monoclonal antibody to be approved in Europe for patients with previously untreated chronic lymphocytic leukaemia.

Dr Sandra Horning, Roche's chief medical officer and head of global product development, said: "Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions."

This comes after the firm recently announced its financial results for the first six months of the year, during which it achieved a year-on-year revenue increase of five percent on a constant exchange rate basis.ADNFCR-8000103-ID-801738233-ADNFCR

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